ISO Cleanroom Standards and Classifications

IQS Directory provides you with the information you need to make an educated cleanroom purchase. We offer a full description for each of the ISO classes and how they correlate with and expand on the earlier FS209E standards. With this information, you can fully understand the types of features and advantages each class and type of cleanroom offers. Our breakdown of the ISO cleanroom standards will help you determine which class of cleanroom is most appropriate for your needs and will help keep your cleanrooms up to these standards. Whatever your cleanroom needs may be, IQS Directory will help you find the right solution!

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Cleanroom Classifications

Cleanrooms are classified by how clean the air is. In Federal Standard 209 (A to D) of the USA, the number of particles equal to and greater than 0.5mm is measured in one cubic foot of air, and this count is used to classify the cleanroom. This metric nomenclature is also accepted in the most recent 209E version of the Standard. Federal Standard 209E is used domestically. The newer standard is TC 209 from the International Standards Organization. Both standards classify a cleanroom by the number of particles found in the laboratory's air. The cleanroom classification standards FS 209E and ISO 14644-1 require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area. In the UK, British Standard 5295 is used to classify cleanrooms. This standard is about to be superseded by BS EN ISO 14644-1.

Cleanrooms are classified according to the number and size of particles permitted per volume of air. Large numbers like "class 100" or "class 1000" refer to FS 209E, and denote the number of particles of size 0.5 mm or larger permitted per cubic foot of air. The standard also allows interpolation, so it is possible to describe e.g. "class 2000."

Small numbers refer to ISO 14644-1 standards, which specify the decimal logarithm of the number of particles 0.1 µm or larger permitted per cubic meter of air. So, for example, an ISO class 5 cleanroom has at most 105 = 100,000 particles per m3.

Both FS 209E and ISO 14644-1 assume log-log relationships between particle size and particle concentration. For that reason, there is no such thing as zero particle concentration. Ordinary room air is approximately class 1,000,000 or ISO 9.

ISO Cleanroom Standards

Before global cleanroom classifications and standards were adopted by the International Standards Organization (ISO), the U.S. General Service Administration's standards (known as FS209E) were applied virtually worldwide. However, as the need for international standards grew, the ISO established a technical committee and several working groups to delineate its own set of standards.

FS209E contains six classes, while the ISO 14644-1 classification system adds two cleaner standards and one dirtier standard (see chart below). The "cleanest" cleanroom in FS209E is referred to as Class 1; the "dirtiest" cleanroom is a class 100,000. ISO cleanroom classifications are rated according to how much particulate of specific sizes exist per cubic meter (see second chart). The "cleanest" cleanroom is a class 1 and the "dirtiest" a class 9. ISO class 3 is approximately equal to FS209E class 1, while ISO class 8 approximately equals FS209E class 100,000.

By law, Federal Standard 209E can be superseded by new international standards. It is expected that 209E will be used in some industries over the next five years, but that eventually it will be replaced internationally by ISO 14644-1.

Airborne Particulate Cleanliness Class Comparison

ISO 14644-1

FEDERAL STANDARD 209E

ISO Class

English

Metric

ISO 1

ISO 2

ISO 3

1

M1.5

ISO 4

10

M2.5

ISO 5

100

M3.5

ISO 6

1,000

M4.5

ISO 7

10,000

M5.5

ISO 8

100,000

M6.5

ISO 9

Airborne Particulate Cleanliness Class (by cubic meter):

CLASS

Number of Particles per Cubic Meter by Micrometer Size

0.1 microns

0.2 microns

0.3 microns

0.5 microns

1 micron

5 microns

ISO 1

10

2

ISO 2

100

24

10

4

ISO 3

1,000

237

102

35

8

ISO 4

10,000

2,370

1,020

352

83

ISO 5

100,000

23,700

10,200

3,520

832

29

ISO 6

1,000,000

237,000

102,000

35,200

8,320

293

ISO 7

352,000

83,200

2,930

ISO 8

3,520,000

832,000

29,300

ISO 9

35,200,000

8,320,000

293,000

ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.

In cleanrooms, particulate concentration changes over time - from the construction and installation of equipment to its operational status. ISO delineates three cleanroom classification standards: as-built, at-rest and operational. As instruments and equipment are introduced and particulates rise, an "as-built" cleanroom becomes an "at-rest" cleanroom. When people are added to the matrix, particulate levels rise still further in the "operational" cleanroom.

ISO 14644-2 describes the type and frequency of testing required to conform to certain standards. The following tables indicate mandatory and optional tests.

Required Testing (ISO 14644-2)

Schedule of Tests to Demonstrate Continuing Compliance

Test Parameter

Class

Maximum Time Interval

Test Procedure

Particle Count Test

<= ISO 5

6 Months

ISO 14644-1 Annex A

> ISO 5

12 Months

Air Pressure Difference

All Classes

12 Months

ISO 14644-1 Annex B5

Airflow

All Classes

12 Months

ISO 14644-1 Annex B4

Optional Testing (ISO 14644-2)

Schedule of Additional Optional Tests

Test Parameter

Class

Maximum Time Interval

Test Procedure

Installed Filter Leakage

All Classes

24 Months

ISO 14644-1 Annex B6

Containment Leakage

All Classes

24 Months

ISO 1464401 Annex B4

Recovery

All Classes

24 Months

ISO 14644-1 Annex B13

Airflow Visualization

All Classes

24 Months

ISO 14644-1 Annex B7

Today, in addition to ISO 14644-1 and ISO 14644-2, eight other cleanroom standards documents are being prepared. Many are in the final voting stage and can be legally used in the trade (see chart).

ISO Document

Title

ISO 14644-1

Classification of Air Cleanliness

ISO 14644-2

Cleanroom Testing for Compliance

ISO 14644-3

Methods for Evaluating and Measuring Cleanrooms and Associated Controlled Environments

ISO and Federal Air Change Rates for Cleanrooms

A critical factor in cleanroom design is controlling air-change per hour (ACH), also known as the air-change rate, or ACR. This refers to the number of times each hour that filtered outside air replaces the existing volume in a building or chamber. In a normal home, an air-conditioner changes room air 0.5 to 2 times per hour. In a cleanroom, depending on classification and usage, air change occurs anywhere from 10 to more than 600 times an hour.

ACR is a prime variable in determining ISO and Federal cleanliness standards. To meet optimal standards, ACR must be painstakingly measured and controlled. And there is some controversy. In an appendix to its ISO 14644-1 cleanliness standard, the International Standards Organization addressed applications for microelectronic facilities only. (ISO classes 6 to 8; Federal Standards 1,000, 10,000 and 100,000.) The appendix contained no ACR standards for pharmaceutical, healthcare or biotech applications, which may require higher ACR regulations.

According to current research, case studies and experiments, using an ACR range (rather than one set standard) is a better guideline for cleanliness classification. This is true because the optimal ACR varies from cleanroom to cleanroom, depending on factors such as internal equipment, staffing and operational purpose. Everything depends on the level of outside contaminants trying to enter the facility versus the level of contaminants being generated on the inside.

The breadth of these ranges reflects how dramatically people and processes affect cleanliness. Low-end figures within each contamination class generally indicate air velocity and air change requirements for an as-built or at-rest facility - where no people are present and no contaminating processes under way. When there are people and processes producing contaminants, more air changes are required to maintain optimal cleanliness standards. For instance, some manufacturers insist on as many as 720 air changes per hour to meet Class 10 standards.

Determining the appropriate number of air changes for a particular application requires careful evaluation of factors such as the number of personnel, effectiveness of garbing protocol, frequency of access, and cleanliness of process equipment.

Jaisinghani's recommendations concur with other recent studies of ACR, which criticize some existing air rate standards (developed in the 1990s) as being unscientific because they are based on fans and filters inferior to today's models. So when these older standards are applied, the resulting ACR is often too high. In fact, some studies have found that reducing the ACR (and its attendant air turbulence) can result in a cleaner atmosphere.

This was demonstrated in a study conducted by Pacific Gas and Electric (San Francisco) and the Lawrence Berkeley National Laboratory (Berkeley). The study measured air change rates in several ISO Class-5 cleanrooms and came to the conclusion that there is "no consistent design strategy for air change rate, even for cleanrooms of the same cleanliness classification."

Lower air change rates result in smaller fans, which reduce both initial investment and construction cost.

Fan power is proportional to the cube of air change rates or airflow. A 30-percent reduction in air change rate results in a power reduction of approximately 66 percent.

By minimizing turbulence, lower airflow may improve cleanliness.

The study focused on Class-5 cleanrooms, concluding that an ACR range of from 250 to 700 air changes per hour is standard, but that "actual operating ACRs ranged from 90 to 625." It added that all of these optimized cleanrooms were certified and performing at ISO Class-5 conditions with these lower ACRs. Finally, the study concluded that rarely does a Class-5 facility require an ACR of more than 300.

The study also found that the "[b]est practice for ACRs is to design new facilities at the lower end of the recommended ACR range," with variable speed drives (VSDs) built in so that air flow adjustments can be made under actual operating conditions.

In his report "An examination of ACRs: An opportunity to reduce energy and construction costs," Peter Rumsey, PE, CEM, essentially concurred with the PG&E-commissioned study by Berkeley. Rumsey issued a caveat, then brushed it aside by citing research subsequent to Berkeley's: "Air cleanliness is a critical component of any cleanroom, far outweighing energy saving priorities. Designers and operators need evidence from others who have tried similar strategies in order to address the perceived risks of lowering air change rates."

Rumsey then went on to cite studies done by International Sematech (Austin, Texas); the Massachusetts Institute of Technology (Cambridge, Mass.); Intel (Santa Clara, Calif.); and Sandia National Laboratories (Albuquerque, N.M.), which echoed the Berkeley study.
In summary, current research and thinking on air change rates indicate that some existing standards are too high and can be lowered while still meeting all ACR criteria.

Such coverage, especially in a large cleanroom, can lead to higher energy consumption, thus increasing costs for both initial construction and ongoing operation. In most cases, a smaller percentage of ceiling coverage produces adequate cleanliness.

This table illustrates the percentage of ceiling coverage recommended for each cleanliness class, again as a range:

Class

Ceiling Coverage (Percentage)

ISO 8 (Class 100,00)

5 - 15%

ISO 7 (Class 10,000)

15 - 20%

ISO 6 (Class 1,000)

25 - 40%

ISO 5 (Class 100)

35 - 70%

ISO 4 (Class 10)

50 - 90%

ISO 3 (Class 1)

60 - 100%

ISO 1 - 2

80 - 100%

Federal and ISO Airflow Velocity Standards

In addition to ACR and ceiling coverage, the third factor integral to maintaining cleanliness is fan-generated air speed. Again, higher airflow velocity results in a "cleaner" cleanroom. The term "ventilation efficiency" refers to the speed of filtered air passing through the cleanroom in addition to the number of air changes per hour (ACH or ACR).

An earlier chart showed a range of recommended air change rates (ACRs) for different classes of cleanrooms. Ranges are given because as-built and at-rest facilities require a smaller ACR than an operational cleanroom, where both people and equipment are actively engaged. Non-operational cleanrooms are found in the lower range; operational cleanrooms higher.

Combining all three factors - ACR, ceiling coverage and airflow velocity-results in the following table:

Class ISO 146144-1 (Federal Standard 209E)

Average Airflow Velocity m/s (ft/min)

Air Changes Per Hour

Ceiling Coverage

ISO 8 (Class 100,000)

0.005 - 0.041 (1 - 8)

5 - 48

5 - 15%

ISO 7 (Class 10,000)

0.051 - 0.076 (10 - 15)

60 - 90

15 - 20%

ISO 6 (Class 1,000)

0.127 - 0.203 (25 - 40)

150 - 240

25 - 40%

ISO 5 (Class 100)

0.203 - 0.406(40 - 80)

240 - 480

35 - 70%

ISO 4 (Class 10)

0.254 - 0.457 (50 - 90)

300 - 540

50 - 90%

ISO 3 (Class 1)

0.305 - 0.457 (60 - 90)

360 - 540

60 - 100%

ISO 1 - 2

0.305 - 508 (60 - 100)

360 - 600

80 - 100%

Before deciding on the appropriate velocity and air changes for your application, Terra Universal recommends careful evaluation of factors such as number of personnel, effectiveness of garbing protocol, access frequency and cleanliness of process equipment. Once the required air change figure is established, the number of required FFUs can be determined using this formula:

Positive Pressure

Cleanrooms are designed to maintain positive pressure, preventing "unclean" (contaminated) air from flowing inside and less-clean air from flowing into clean areas. The idea is to ensure that filtered air always flows from cleanest to less-clean spaces. In a multi-chambered cleanroom, for instance, the cleanest room is kept at the highest pressure. Pressure levels are set so that the cleanest air flows into spaces with less-clean air. Thus, multiple pressure levels may need to be maintained.

A differential air pressure of 0.03 to 0.05 inches water gauge is recommended between spaces. In order to ensure that pressure differentials remain constant when doors are opened, or other events occur, control systems must be in place.

Laminar and Turbulent Air Flow

ISO 5 (Class 100) and cleaner facilities rely on unidirectional, or laminar, airflow. Laminar airflow means that filtered air is uniformly supplied in one direction (at a fixed velocity) in parallel streams, usually vertically. Air is generally recirculated from the base of the walls back up to the filtering system.

ISO 6 (Class 1,000) and above cleanrooms generally utilize a non-unidirectional, or turbulent, airflow. This means the air is not regulated for direction and speed. The advantage of laminar over turbulent airflow is that it provides a uniform environment and prevents air pockets where contaminants might congregate.